A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

NCT05769608
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
285
clinicaltrials.gov
Lead sponsor
Mineralys Therapeutics Inc.
clinicaltrials.gov
Start date
2023-03-13
clinicaltrials.gov
Number of sites
104
clinicaltrials.gov

Summary
A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.
clinicaltrials.gov
Short title
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
clinicaltrials.gov
Official title
A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2025-01-15
clinicaltrials.gov
First posted
2023-03-15
clinicaltrials.gov
Registry last updated
2026-01-20
clinicaltrials.gov
Primary completion date
2025-01-15
clinicaltrials.gov
Start date
2023-03-13
clinicaltrials.gov

Actual participants
285
clinicaltrials.gov
Participants
285
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
7
clinicaltrials.gov
Number of sites
104
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Mineralys Therapeutics Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05769608
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05769608
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Care providers
Sources for study design
clinicaltrials.gov

  1. Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP)

    Timeframe: Baseline (Randomization) to Week 12

  1. Change from baseline in 24-hour average ABPM SBP at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4

  2. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Timeframe: at Week 4

  3. Change from baseline in 24-hour average ABPM SBP at Week 4 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4

  4. Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 4 (within-subjects analysis)

    Timeframe: Baseline to Week 12

  5. Change from baseline in 24-hour average ABPM SBP at Week 4, by number of AHT medications in the standardized AHT regimen (2 and 3) in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4

  6. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12 in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 12

  7. Change from baseline in 24-hour average ABPM SBP at Week 12 by obesity status in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 12

  8. Change from baseline in daytime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4 and Week 12

  9. Change from baseline in AOBP SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4 and Week 12

  10. Change from baseline in nighttime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 4 and Week 12

  11. Change from baseline in 24-hour average ABPM SBP at Week 12, in subjects randomized to lorundrostat (pooled dosages) compared to subjects randomized to placebo

    Timeframe: Baseline to Week 12

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. At least 18 years of age at the time of signing the informed consent form
  2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
  3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg
  4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
  5. BMI of 18-40 kg/m2 inclusive at Screening

  1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  2. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  3. Serum sodium <135 mmol/L at Screening
  4. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
  5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening
Sources for eligibility
clinicaltrials.gov

  • Cardiology, P.C. - BirminghamBirmingham, United States
  • University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension ProgramBirmingham, United States
  • Chandler Clinical TrialsChandler, United States
  • Brown Road Family MedicineMesa, United States
  • Scottsdale Clinical Trials (Elite Clinical Network)Scottsdale, United States
  • Fiel Family & Sports MedicineTempe, United States
  • Noble Clinical ResearchTucson, United States
  • Del Sol Research Management, LLCTucson, United States
  • The Medical Research Group Inc.Fresno, United States
  • Marvel Clinical ResearchHuntington Beach, United States
  • University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United States
  • Clinical Trials ResearchLincoln, United States
  • Cedars-Sinai Medical CenterLos Angeles, United States
  • Catalina Research InstituteMontclair, United States
  • Northridge Clinical TrialsNorthridge, United States
  • University of California Irvine Medical CenterOrange, United States
  • Triwest Research AssociatesSan Diego, United States
  • San Jose Clinical TrialsSan Jose, United States
  • Blue Coast Research CenterVista, United States
  • Accelerated Enrollment Solutions (AES)- VistaVista, United States
  • Delta Waves, Inc.Colorado Springs, United States
  • CMR of Greater New HavenHamden, United States
  • Indago Research & Health Center, Inc.Hialeah, United States
  • Clinical Neuroscience Solutions, Inc (Jacksonville)Jacksonville, United States
  • Reserka, LLCMiami, United States

And 79 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)